FDA approves first automated insulin delivery pump

The Food and Drug Administration has approved a new insulin pump for people 14 years of age and older with Type 1 diabetes that promises to reduce the complications and worry involved in controlling the disease.

The new device “can provide people with Type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin,” according to Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

Insulin pump systems that automatically shut off insulin flow when blood sugar levels get too low are already available in the U.S. for people 16 and older. Yet current devices do not automatically deliver insulin when a person’s blood sugar level is high.

“However, you will still need to participate in management as well as tell the pump how much to take with food,” she said.

Safe for younger teens

The FDA evaluated data from a clinical trial of the device in 124 patients with Type 1 diabetes. During a three-month period during which participants frequently used the device, there were no episodes of some of the more serious problems associated with Type 1 diabetes, such as severe hypoglycemia (low blood sugar).

Known risks associated with use of the system include skin irritation or redness around the device’s infusion patch. The study results were published earlier this month in the Journal of the American Medical Association.

How it works

This type of system has been called an “artificial pancreas” because it adjusts insulin levels with little or no input from the user. A sensor attached to the body measures glucose levels under the skin every five minutes and automatically administers or withholds insulin through a pump and catheter strapped to the body.

While the device automatically adjusts insulin levels, users do need to manually request insulin doses to counter carbohydrate consumption from meals and adjust the sensor twice a day by carrying out finger-prick tests to measure blood sugar.

As part of its approval, the FDA is requiring a post-market study to better understand how the device performs in “real-world” settings compared to the “controlled” setting of a clinical trial.

This new device, called the MiniMed 630G, may eventually benefit even younger patients and may particularly help children at risk of nocturnal hypoglycemia who would otherwise need to be wakened frequently to check their glucose levels. Medtronic, the Dublin, Ireland-based company that makes it, is conducting trials in diabetic children between 7 and 13 years old.

“Overall, I would say it is a great step forward, but with some limitations,” said Dr. Stephenson.

Patients should be aware the new integrated pump will be expensive. Check with your insurance carrier prior to purchasing a pump and supplies. Many carriers will cover them, but some do not. According to Medtronic, the device will be available spring 2017.

About Type 1 diabetes

The human pancreas naturally supplies a low, continuous rate of insulin, known as basal or background insulin. In patients with diabetes, the body’s ability to produce or respond to insulin is impaired.

According to the Centers for Disease Control and Prevention, about 5 percent of people with diabetes have Type 1. Also known as juvenile diabetes, Type 1 is typically diagnosed in children and young adults. Because the pancreas does not make insulin in people with Type 1 diabetes, patients have to consistently monitor their glucose levels throughout the day and have insulin therapy through injection with a syringe, an insulin pen or insulin pump to avoid becoming hyperglycemic (high glucose levels).

In addition, management of Type 1 diabetes includes following a healthy eating plan and physical activity.

You can read more about FDA approval of the new insulin pump here. JAMA has more details about the results of the clinical trial.

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